Tom Møller

Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

Objective To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease. Design Randomised controlled trial. Setting Two university hospitals in Copenhagen, Denmark. Participants 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow-up. Intervention Supervised exercise comprising high intensity cardiovascular and resistance training, relaxation and body awareness training, massage, nine hours weekly for six weeks in addition to conventional care, compared with conventional care. Main outcome measures European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo2max). Statistical methods The general linear model was used for continuous outcome while analysis of associates between categorical outcomes was performed as analysis of marginal homogeneity in contingency tables. Results Adjusted for baseline score, disease, and demographic covariates, the intervention group showed an estimated improvement at six weeks for the primary outcome, fatigue, of −6.6 points (95% confidence interval −12.3 to −0.9, P=0.02; effect size=0.33, 0.04 to 0.61). Significant effects were seen on vitality (effect size 0.55, 95% CI 0.27 to 0.82), physical functioning (0.37, 0.09 to 0.65), role physical (0.37, 0.10 to 0.64), role emotional (0.32, 0.05 to 0.59), and mental health (0.28, 0.02 to 0.56) scores. Improvement was noted in physical capacity: estimated mean difference between groups for maximum oxygen consumption was 0.16 l/min (95% CI 0.1 to 0.2, P<0.0001) and for muscular strength (leg press) was 29.7 kg (23.4 to 34.9, P<0.0001). No significant effect was seen on global health status/quality of life. Conclusion A supervised multimodal exercise intervention including high and low intensity components was feasible and could safely be used in patients with various cancers who were receiving adjuvant chemotherapy or treatment for advanced disease. The intervention reduced fatigue and improved vitality, aerobic capacity, muscular strength, and physical and functional activity, and emotional wellbeing, but not quality of life. Trial registration Current Controlled trials ISRCTN05322922.

Safe and feasible outpatient treatment following induction and consolidation chemotherapy for patients with acute leukaemia

Traditionally, patients with acute leukaemia are admitted to hospital during chemotherapy‐induced pancytopenia, although a few recent reports have reported the feasibility and safety of outpatient treatment. We have developed an outpatient treatment programme for patients with acute leukaemia incorporating comprehensive patient education for self‐care management at home during pancytopenia and involvement of patients in care of their tunnelled central venous catheter (CVC). During neutropenia, patients are treated with prophylactic ciprofloxacine, amoxicillin/clavulanic acid and fluconazole. Herein, we report the results of outpatient treatment of 60 patients with acute leukaemia (54 with acute myeloid leukaemia) followed prospectively in the period from March 2004 to 2007. After induction chemotherapy, outpatient treatment was possible after 48 of 73 induction courses, with no readmission in 19 of these (40%). A total of 129 consolidation courses were administered with outpatient treatment following 116 of these, with no readmission in 69 (59%). The median number of days spent at home with neutrophils below 0.5 × 109/L was 8 d per course following induction and 12 d following consolidation chemotherapy. The predominant cause of readmission was neutropenic fever, in most instances of unknown origin. Coagulase‐negative staphylococci and Enterococcus faecium were the most frequently identified bacteria in blood cultures, whereas only four positive blood cultures with multiresistant Escherichia coli were identified in the entire patient cohort, the latter exclusively observed in patients receiving antibiotic prophylaxis. The majority of the patients were able to take care of their CVC including change in dressing and heparin flushing. There were 12 CVC‐related infections. There were no treatment‐related deaths. We conclude that outpatient treatment of patients with acute leukaemia is feasible and safe.

Self-reported physical activity behaviour; exercise motivation and information among Danish adult cancer patients undergoing chemotherapy

BACKGROUND Physical activity is considered an important and determining factor for the cancer patients physical well-being and quality of life. However, cancer treatment may disrupt the practice of physical activity, and the prevention of sedentary lifestyles in cancer survivors is imperative. PURPOSE The current study aimed at investigating self-reported physical activity behaviour, exercise motivation and information in cancer patients undergoing chemotherapy. METHODS AND SAMPLE Using a cross-sectional design, 451 patients (18-65 years) completed a questionnaire assessing pre-illness and present physical activity; motivation and information received. RESULTS Patients reported a significant decline in physical activity from pre-illness to the time in active treatment (p<0.001). Amongst the respondents, 68% answered that they believed exercise to be beneficial; and 78% claimed not exercising as much as desired. Exercise barriers included fatigue (74%) and physical discomfort (45%). Present physical activity behaviour was associated with pre-illness physical activity behaviour (p<0.001), exercise belief (p<0.001), and diagnosis (p<0.001). More patients <40 years than patients >40 years (OR 0.36, p<0.001); more men than women (OR 2.12, p<0.001); and more oncological than haematological patients (OR 0.41, p<0.001) stated being informed about physical activity. Moreover patients who claimed to have been informed about exercise were more in agreement with being able to exercise while undergoing chemotherapy (OR 1.69, p=0.023). CONCLUSIONS This study suggests that Danish adult cancer patients in chemotherapy experience a significant decline in physical activity behaviour. Results indicate a general positive interest in physical activity amongst the patients, which however may be only suboptimally exploited.

Struggling with cancer and treatment: young athletes recapture body control and identity through exercise: qualitative findings from a supervised group exercise program in cancer patients of mixed gender undergoing chemotherapy

Cancer and treatment can negatively affect the bodys performance and appearance. Exercise has been tested in a few studies for altered body image among middle‐aged women with breast cancer. The aim of the study was to explore how young pre‐cancer athletes of both genders experience disease‐ and treatment‐related physical fitness and appearance changes while undergoing chemotherapy and participating in a 6‐week group exercise intervention. A prospective, explorative study using semi‐structured interviews was conducted before and at termination of the intervention. The study included 22 cancer patients (median age 28 years). The young athletes experienced a change from a high level of physical activity, body satisfaction and a positive self‐identity to a low level of physical activity, body denial and a negative self‐identity. In the program, the patients experienced increased physical strength and recapture of certain aspects of their former positive body perception. Deterioation of muscle functions caused by chemotherapy was particularly painful to these patients, independent of gender and age. Young physically active patients are heavily dependent on their physical capacity, body satisfaction and self‐identity. This should be taken into account when designing programs to rehabilitate and encourage these patients through the often‐strenuous antineoplastic treatments.

Exercise may reduce depression but not anxiety in self-referred cancer patients undergoing chemotherapy. Post-hoc analysis of data from the ‘Body & Cancer’ trial

Abstract Background. The diagnosis and treatment of cancer may cause clinically significant and persistent psychological morbidity. The objective of this study was to determine the short-term effect of a six week exercise intervention on anxiety and depression in cancer patients undergoing chemotherapy (The ‘Body & Cancer’ trial). Methods. Two hundred and nine self-referred patients (52 males, 157 females, mean age 47 years) were randomised into an intervention group and a waiting-list control group. Anxiety and depression was measured by the Hospital Anxiety and Depression Scale. Results. At baseline, 23.5% and 11.5% of the population scored >8 on the HADS and were classified as suspicious or definite cases of anxiety and depression, respectively. Adjusted for baseline score, disease and demographic covariates the estimated intervention effect showed improvement at six weeks for depression of −0.7 points (95% confidence interval [CI] −1.27 to −0.14, p = 0.0153). No significant effect was seen on anxiety. Further subanalysis, including only suspicious or definite cases of depression, resulted in an estimated intervention effect of −2.53 points (95% CI, −0.64 to −0.42, p = 0.021). Conclusion. Anti-depressant effects could be caused by exercise in self-referred cancer patients undergoing chemotherapy. Dedicated trials and follow-up studies are needed to clarify the optimal duration and content of exercise interventions to meet the needs of clinically depressive or anxious patients.

The emerging role of exercise and health counseling in patients with acute leukemia undergoing chemotherapy during outpatient management

This study investigates the feasibility, safety and benefits of a 6-week exercise and health counseling intervention in patients with acute leukemia undergoing consolidation chemotherapy during outpatient management. Seventeen of twenty patients completed study requirements (85%), adherence to exercise was 73% and for health counseling 92%. There were improvements in the 6-min-walk-distance (p=0.0013), sit-to-stand test (p=0.0062), the right and left biceps arm-curl tests p=0.0002 and p=0.0002, respectively; health-related quality of life (p=0.0209) (FACT-An), vitality (p=0.0015), mental health (p=0.0471) and physical component scale (p=0.0295) (SF36). Significant reduction in the symptom burden (p=0.0021) and symptom interference on daily life activities (p=0.0069) (MDASI). No adverse reactions were observed.

Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

BackgroundPatients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy. Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and supervised counseling and exercise program.Methods/designThis paper presents the study protocol: Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) trial, a two center, randomized controlled trial of 70 patients with acute leukemia (35 patients/study arm) following induction chemotherapy in the outpatient setting. Eligible patients will be randomized to usual care or to the 12 week exercise and counseling program. The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training (moderate to high intensity 70 - 80%) on an ergometer cycle, strength exercises using hand weights and relaxation exercise. Individual health counseling sessions include a self directed home walk program with a step counter. The primary endpoint is functional performance/exercise capacity (6 minute walk distance). The secondary endpoints are submaximal VO2 max test, sit to stand and bicep curl test, physical activity levels, patient reported outcomes (quality of life, anxiety and depression, symptom prevalence, intensity and interference). Evaluation of clinical outcomes will be explored including incidence of infection, hospitalization days, body mass index, time to recurrence and survival. Qualitative exploration of patients’ health behavior and experiences.DiscussionPACE-AL will provide evidence of the effect of exercise and health promotion counseling on functional and physical capacity, the symptom burden and quality of life in patients with acute leukemia during out patient management. The results will inform clinical practice exercise guidelines and rehabilitation programs for patients undergoing treatment for acute leukemia. Optimizing the treatment and care pathway may ease the transition for patients from illness to the resumption of everyday activities.Trial registrationClinicalTrials.gov Identifier: NCT01404520.

At cancer diagnosis: a 'window of opportunity' for behavioural change towards physical activity. A randomised feasibility study in patients with colon and breast cancer.

Introduction Challenges exist in identifying, recruiting and motivating sedentary patients with cancer to initiate physical activity towards recommended levels. We hypothesise that the onset period of adjuvant chemotherapy can be ‘the open window of opportunity’ to identify and motivate sedentary patients with breast and colon cancers, at risk for developing coronary heart disease, to initiate and sustain lifestyle changes. Aims To investigate the feasibility of oncologists/nurses screening for physical inactivity, in order to identify and recruit an at-risk population of sedentary patients with breast or colon cancer at the onset of adjuvant chemotherapy. Furthermore, the study will examine the adherence to one of two multimodal exercise interventions lasting 12 weeks; (1) hospital-based, high intensity, group exercise intervention (2) home-based, low intensity, individual, pedometer intervention. Both arms will be compared with a control group. Methods and analyses All newly referred patients will be screened for sedentary behaviour, using national recommendations. Testing at baseline, 6, 12 and 39 weeks will include; (1) physiological testing (VO2-peak, one repetition maximum muscle strength and lung function (2) fasting full body dual-energy X-ray absorptiometry scan (3) fasting blood glucose, insulin, lipids and cholesterols, (4) psychometric questionnaires (general well-being, quality of life, anxiety and depression, motivational readiness). The randomised controlled trial feasibility design is selected in order to examine barriers for recruitment, programme adherence, safety aspects and potential efficacy to the interventions during adjuvant chemotherapy. Ethics and dissemination The Scientific Committee of the Capital Region (case No. H-1-2011-131) and the Danish Data Protection Agency (j. No. 2011-41-6349) approved the study. Data will be entered and locked into a database hosted by the Copenhagen Trial Unit, Rigshosptialet. Data will be available for analyses to project members and the trial statistician after the 45 included patients have completed the 12-week test. Results will be published in peer-reviewed scientific journals. Trial registration Current Controlled Trials ISRCTN24901641.

The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: a randomised feasibility study

Introduction Anti-neoplastic treatment is synonymous with an inactive daily life for a substantial number of patients. It remains unclear what is the optimal setting, dosage and combination of exercise and health promoting components that best facilitate patient adherence and symptom management in order to support cardio-respiratory fitness and lifestyle changes in an at-risk population of pre-illness physically inactive cancer patients. Methods Patients with breast or colon cancer referred to adjuvant chemotherapy and by the oncologists pre-screening verified as physically inactive were eligible to enter a randomised three-armed feasibility study comparing a 12-week supervised hospital-based moderate to high intensity exercise intervention or alternate an instructive home-based12-week pedometer intervention, with usual care. Results Using a recommendation based physical activity screening instrument in order to correspond with cardio-respiratory fitness (VO2 peak) proved to be an applicable method to identify pre-illness physically inactive breast and colon cancer patients. The study demonstrated convincing recruitment (67%), safety and intervention adherence among breast cancer patients; while the attendance rate for colon cancer patients was notably lower (33%). VO2-peak declined on average 12% across study groups from baseline to 12 weeks though indices towards sustaining watt performance and reduce fat mass favoured the hospital-based intervention. Pedometer use was well adapted in both breast and colon cancer patients. Conclusions Despite a fair adherence and safety, the current study calls into question whether aerobic exercise, regardless of intensity, is able to increase VO2-peak during texane-based chemotherapy in combination with Neulasta in physically inactive breast cancer patients. Trial Registration: ISRCTN24901641

Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial ‘PACE-AL’

Management of acute leukemia has seen a trend toward outpatient treatment strategies to reduce the negative effects of prolonged hospitalization.[1][1] Outpatient treatment requires frequent hospital visits with ongoing transfusion support, symptom management, and infection surveillance. Physical